Psychosocial Syndemics of Heart Failure

Psychosocial Syndemics and Multimorbidity in Patients With Heart Failure - R01 HL151431

Heart failure (HF) is a common and debilitating chronic disease with a poor prognosis. Many patients with HFhave psychiatric problems such as depression and other medical disorders such as lung or kidney disease.This study will examine the effects that these psychiatric and medical disorders have on HF outcomes.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Hospitalization

Detailed Description

Approximately 6.2 million Americans have heart failure (HF) and the prevalence is increasing rapidly. HF is a common cause of hospitalization and mortality in older adults, and the cost of hospital care for HF is skyrocketing. One reason why HF is so burdensome and costly is that it is often complicated by cardiovascular and noncardiovascular comorbidities, especially in older patients. Psychiatric and medical disorders that are risk factors for incident HF persist after HF has developed, and additional comorbidities accumulate as patients with HF grow older. Thus, HF is embedded within a larger pattern of multimorbidity. Unfortunately, most trials of HF therapies as well as many other studies of HF have excluded patients with complex psychiatric and medical comorbidities or severe cognitive impairment. This has left large gaps in research on the care of older adults with HF. In addition, research on socioeconomic risk factors and health disparities has not been integrated with research on multimorbidity in HF. Heart failure is only one of multiple challenges facing patients with multimorbidity, stressful socioeconomic circumstances, and psychosocial problems, but the fragmentation of research on HF has left us with little understanding of patients with complex psychosocial problems. The purpose of this study is to identify combinations of comorbidities and health disparities may affect HF outcomes and require different mixtures of medical, psychological, and social services to address. It will encompass both psychiatric and medical comorbidities but will emphasize the role of psychiatric comorbidities. Syndemics theory is a useful framework for studying this type of psychosocial and medical complexity. Syndemics, also known as synergistic epidemics, occur when there are adverse interactions between prevalent disorders that concentrate in populations that are vulnerable due to adverse socioeconomic or environmental conditions. The syndemics framework has yielded important insights into a number of other disorders, but it has not been used to study the complex psychosocial problems of patients with HF. To our knowledge, this will be the first study of the syndemics of psychiatric and medical comorbidities in heart failure. The multimorbidity framework is an alternative approach for investigating the effects of multiple comorbidities on health outcomes. The specific aims of the study are: 1) to determine the coprevalence of major psychiatric and medical comorbidities in patients with HF (n=535); 2) to determine whether coprevalent comorbidities have synergistic effects on all-cause readmission and mortality risks, heart failure self-care, and perceived global health; 3) to identify vulnerable subpopulations of patients with HF who have higher coprevalences of syndemic comorbidities compared to less vulnerable subpopulations; 4) to determine the extent to which syndemic comorbidities explain adverse HF outcomes (readmissions and mortality, poor self-care, and poor perceived health) in vulnerable subgroups of patients with HF; and 5) to determine the effects of multimorbidity on readmissions, mortality risk, self-care, and quality of life.

• Study Type: Observational
• Enrollment (Estimated): 535

Contacts and Locations

• Study Contact: Name: Kenneth E Freedland, PhD; Phone Number: 314-286-1311; Email: freedlak@wustl.edu
• Study Contact Backup: Name: Samantha Boettinger, RN; Phone Number: 314-286-1315; Email: samantha.boettinger@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Barnes-Jewish Hospital at Washington University Medical Center
      • Contact: Samantha Boettinger, RN; Phone Number: 314-286-1315; Email: samantha.boettinger@wustl.edu
      • Contact: Iris Csik, MSW, LCSW; Phone Number: 314-286-1310; Email: csiki@wustl.edu
      • Principal Investigator: Kenneth E Freedland, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure who were discharged from a hospital in the St. Louis, Missouri area within the past month.

Description

Inclusion Criteria:

• Discharged from an inpatient hospitalization within the past month, AND
• had a clinical diagnosis of HF at admission to or discharge from the hospital, AND
• met the European Society of HF diagnostic criteria during the hospital stay.

Exclusion Criteria:

• patient's physician advises against participation in the study, OR
• patient refuses to participate, OR
• patient's legally authorized representative refuses to allow patient to participate, OR
• isolated right HF (cor pulmonale), OR
• reversible HF due to valve disease with impending surgical correction.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Heart Failure; Patients with heart failure who were discharged within the past month after hospitalization for any reason.	Other: Hospitalization; Hospitalization for any reason

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital readmissions	Number of hospital readmissions for HF or for other reasons	4 years or less, depending upon available follow-up time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HF Self-Care	Self-Care of Heart Failure Index v7.2 questionnaire; score range, 0-100 (higher is better)	Baseline
Global health	PROMIS Global Health V1.2 questionnaire 8-item short form; score range, 0-100 (higher is better)	Baseline
Medication management	PROMIS Manage Medications questionnaire 4-item short form; score range, 0-100 (higher is better)	Baseline
Activities of daily living	PROMIS Manage Daily Activities questionnaire 8-item short form; score range, 0-100 (higher is better)	Baseline
Perceived stress	Perceived Stress Scale (Cohen et al., 1983); score range, 0-40 (higher is worse)	Baseline

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Kenneth E Freedland, PhD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 1R01HL151431 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study data will be shared on request after the closure of the study.
• IPD Sharing Time Frame: The dataset is expected to be finalized in mid- to late-2024.
• IPD Sharing Access Criteria: Affiliation with a recognized research institution
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No